BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD BEARING

    MDR report key: 10012894 · Received April 30, 2020

    Report

    Report Number
    3002806535-2020-00237
    Event Type
    Injury
    Date Received
    April 30, 2020
    Report Date
    May 21, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN TURKEY. BIOMET UK LTD HAVE ATTEMPTED TO CONTACT THE JOURNAL ARTICLE AUTHOR, HOWEVER, THE AUTHOR HAS INFORMED THAT NO FURTHER INFORMATION IS AVAILABLE. THE PRODUCT HAS NOT BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION, THEREFORE, A THOROUGH INVESTIGATION HAS NOT BEEN POSSIBLE. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. THE ITEM NUMBER AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY AND THE COMPLAINT HISTORY WAS NOT PROVIDED. TREND ANALYSIS COULD NOT BE PERFORMED AS PRODUCT NUMBERS ARE NOT AVAILABLE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT AND WITHOUT ADEQUATE INFORMATION RECEIVED REGARDING THE EVENT, ROOT CAUSE COULD NOT BE DETERMINED AND THEREFORE RISK COULD NOT BE ASSESSED AGAINST OCCURRENCE OR ANY NEW PREVIOUSLY UNIDENTIFIED RISK. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BASED ON JOURNAL ARTICLE ENTITLED THE LONG-TERM RESULTS OF CEMENTED OXFORD UNICOMPARTMENTAL KNEE ARTHROPLASTY: A SINGLE-CENTER EXPERIENCE THAT 156 PATIENTS UNDERWENT OXFORD MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA). HOWEVER, FIVE OF THESE PATIENTS DIED DURING THE STUDY AND 36 PATIENTS COULD NOT BE REACHED AT THE FINAL FOLLOW-UP VISIT. REVISION SURGERIES WERE PERFORMED FOR ALL THESE PATIENTS. TOTAL OF 115 PATIENTS, 16 MALES AND 99 FEMALES (AGE RANGE: 50 TO 88). AMONG THEM, 17 PATIENTS UNDERWENT REVISION SURGERY DUE TO INSERT DISLOCATION. THIS COMPLAINT REPORTS THE REVISION DUE TO INSERT DISLOCATION.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 17 REVISIONS WERE PERFORMED DUE TO INSERT DISLOCATION ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478898 UNKNOWN OXFORD BEARING KNEE PROTHESIS HRY BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention